COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05252923

Kirill Lobastov, PhD

lobastov_kv@hotmail.com

2022-02-23

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: over 18 years old male or female documented pcr sars-cov-2 positive test covid-19 convalescence (define as at least 10 days after the onset of symptoms, no fever for at least 24 hours without the use of antipyretics and improvement of respiratory symptoms) informed consent signed clinical severity presentation of severe the disease is classified as severe if one of the following conditions is met: respiratory distress, respiratory rate ≥30/min oxygen saturation on room air at rest ≤93%. partial pressure of oxygen in arterial blood/fio2 ≤300 mm hg. or critical if one of the following conditions is met. respiratory failure and mechanical ventilation are required. shock occurs another organ dysfunction is present risk of health complication >50% according to the health risk calculator less than 14 days of hospital discharge.

concomitant use of another anticoagulant known pregnancy known hypersensitivity to sulodexide need for hospital care at screening renal insufficiency with crcl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis. blood platelet count < 30 000/µl other conditions that are judged to carry an increased risk of bleeding as judged by the investigator more than 30 days of clinical onset

2

Pirogov Russian National Research Medical University

18

100

Russia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

30

Serum level of soluble Thrombomodulin

None

Phase 4

[{"arm_notes": "", "treatment_id": 1245, "treatment_name": "Sulodexide", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]